PMID- 23700194
OWN - NLM
STAT- PubMed-not-MEDLINE
DCOM- 20130621
LR  - 20231106
IS  - 1869-6953 (Print)
IS  - 1869-6961 (Electronic)
IS  - 1869-6961 (Linking)
VI  - 4
IP  - 1
DP  - 2013 Jun
TI  - Safety and tolerability of sitagliptin in type 2 diabetes: pooled analysis of 25 
      clinical studies.
PG  - 119-45
LID - 10.1007/s13300-013-0024-0 [doi]
AB  - INTRODUCTION: In a previous pooled analysis of 19 double-blind clinical studies 
      conducted by Merck, which included data available as of July 2009 on 10,246 
      patients with type 2 diabetes (T2DM), treatment with sitagliptin was shown to be 
      generally well tolerated compared with treatment with control agents. As the 
      sitagliptin clinical development program continues, additional studies with 
      sitagliptin have been completed. The present analysis updates the safety and 
      tolerability assessment of sitagliptin by examining pooled data from 25 
      double-blind clinical studies. METHODS: The present analysis included data from 
      14,611 patients in 25 studies with T2DM who received either sitagliptin 
      100 mg/day (n = 7,726; sitagliptin group) or a comparator agent (n = 6,885; 
      non-exposed group). These studies represent all randomized, double-blind trials 
      conducted by Merck that included patients treated with the usual clinical dose of 
      sitagliptin (100 mg/day) for between 12 weeks and 2 years, and for which results 
      were available as of December 2011. These studies assessed sitagliptin, versus 
      comparator agents, taken as monotherapy, initial combination therapy with 
      metformin or pioglitazone, or as add-on combination therapy with other 
      antihyperglycemic agents (metformin, pioglitazone, a sulfonylurea +/- metformin, 
      insulin +/- metformin, or metformin + pioglitazone or rosiglitazone). Patient-level 
      data from each study were used to evaluate between-group differences in the 
      exposure-adjusted incidence rates of adverse events (AEs). RESULTS: Overall 
      incidence rates of AEs and drug-related AEs were higher in the non-exposed group 
      compared with the sitagliptin group. Incidence rates of specific AEs were 
      generally similar between the two groups, except for higher incidence rates of 
      hypoglycemia related to the greater use of a sulfonylurea and diarrhea related to 
      the greater use of metformin in the non-exposed group, and of constipation in the 
      sitagliptin group. Treatment with sitagliptin was not associated with an 
      increased risk of major adverse cardiovascular events, malignancy, or 
      pancreatitis. CONCLUSION: In this updated pooled safety analysis of data from 
      14,611 patients with T2DM, sitagliptin 100 mg/day was generally well tolerated in 
      clinical trials of up to 2 years in duration.
FAU - Engel, Samuel S
AU  - Engel SS
AD  - Merck Sharp & Dohme Corp., Whitehouse Station, NJ, USA, samuel.engel@merck.com.
FAU - Round, Elizabeth
AU  - Round E
FAU - Golm, Gregory T
AU  - Golm GT
FAU - Kaufman, Keith D
AU  - Kaufman KD
FAU - Goldstein, Barry J
AU  - Goldstein BJ
LA  - eng
PT  - Journal Article
DEP - 20130523
PL  - United States
TA  - Diabetes Ther
JT  - Diabetes therapy : research, treatment and education of diabetes and related 
      disorders
JID - 101539025
EIN - Diabetes Ther. 2013 Dec;4(2):487. PMID: 23838842
PMC - PMC3687098
EDAT- 2013/05/24 06:00
MHDA- 2013/05/24 06:01
PMCR- 2013/05/23
CRDT- 2013/05/24 06:00
PHST- 2013/03/29 00:00 [received]
PHST- 2013/05/24 06:00 [entrez]
PHST- 2013/05/24 06:00 [pubmed]
PHST- 2013/05/24 06:01 [medline]
PHST- 2013/05/23 00:00 [pmc-release]
AID - 24 [pii]
AID - 10.1007/s13300-013-0024-0 [doi]
PST - ppublish
SO  - Diabetes Ther. 2013 Jun;4(1):119-45. doi: 10.1007/s13300-013-0024-0. Epub 2013 
      May 23.